Healthcare Roundup- COVID-19 vaccine developers rally, Trial of AstraZeneca COVID-19 vaccine may resume next week
COVID-19 vaccine developers rally on AstraZeneca study pause
Many COVID-19 vaccine players are in the green premarket in apparent response to a potential safety signal in a Phase 3 study of AstraZeneca’s (NYSE:AZN) AZD1222. AZN is down 2% on light volume.
Selected tickers: Sanofi (NASDAQ:SNY) (+2%), GlaxoSmithKline (NYSE:GSK) (+2%), Pfizer (NYSE:PFE) (+2%), BioNTech SE (NASDAQ:BNTX) (+5%), Moderna (NASDAQ:MRNA) (+5%), Dynavax (NASDAQ:DVAX) (-2%); Novavax (NASDAQ:NVAX) (+7%), iBio (NYSEMKT:IBIO) (+8%), Vaxart (NASDAQ:VXRT) (+4%), Inovio Pharmaceuticals (NASDAQ:INO) (+6%), Heat Biologics (NASDAQ:HTBX) (+4%), CureVac (NASDAQ:CVAC) (+4%)
Trial of AstraZeneca COVID-19 vaccine may resume next week – Financial Times
The Financial Times reports that the large-scale clinical trial evaluating AstraZeneca (AZN -0.9%) and the University of Oxford’s COVID-19 vaccine candidate, AZD1222, could restart early next week.
The company voluntarily suspended the study yesterday after one participant in the UK experienced a serious adverse reaction, a rare inflammatory condition affecting the spinal cord called transverse myelitis that is caused by infections or immune system disorders.
According to a person close to the matter, it is not unusual for vaccine trials to be paused (this is the second time in this study). Wellcome Trust’s Jeremy Farrar says, “It is very unusual to go through a vaccine trial and not to pause it.”
Shares were down 2.5% intraday before recovering. Turnover three hours into the session is ~8.2M shares, 24% above normal.
Update: A company spokesperson stated that the patient in question has not been definitively diagnosed with transverse myelitis. A final diagnosis will not be made until more tests are performed. The results will be sent to an independent safety committee that will review the event and establish said final diagnosis. The person also confirmed that the study was temporarily paused in July to allow for a safety review after one volunteer was confirmed to have an undiagnosed case of multiple sclerosis, determined to be unrelated to the vaccine.
Pfizer/BioNTech COVID-19 vaccine candidate shows encouraging action in preclinical studies
Pfizer (NYSE:PFE) and development partner BioNTech SE (NASDAQ:BNTX) announce preliminary results from preclinical studies of COVID-19 nucleoside-modified messenger RNA vaccine candidate BNT162b2.
In a viral infection model, rhesus macaques received two injections of 100 µg BNT162b2 or saline, then challenged 55 days after the second dose with a very high viral inoculum of ~1M plaque forming units of SARS-CoV-2 via intranasal and intratracheal routes. Animals immunized with BNT162b2 experienced reduced viral infection with no viral RNA detected in the lower respiratory tract. Most of the non-immunized animals showed evidence of viral RNA.
BNT162b2 induced potent SARS-CoV-2 neutralizing antibodies and viral antigen-specific CD4+ and CD8+ T cells. After two shots of either 30 µg or 100 µg of BNT162b2 21 days apart, neutralization titers were 962 in the 30 µg group and 1,689 in the 100 µg group. Geometric mean titers persisted to at least day 56 at levels higher than a panel of human convalescent sera.
BNT162b2 vaccination elicited a high frequency of CD4+ T cells that produced IFN-ɣ, IL-2, and TNF-α. Almost no IL-4 producing CD4+ cells were detectable, indicating a TH1-biased response, an immune profile believed to promote vaccine safety. It also elicited spike-specific IFN-ɣ producing CD8+ T cell responses, which is thought to promote an antiviral effect.
In a mouse model, a single immunization of BNT162b2 (0.2, 1.0 or 5.0 µg) generated B cell and T cell immune responses. SARS-CoV-2 pseudovirus neutralizing activity increased steadily to day 28, the last day titers were reported. CD4+ and CD8+ T cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFNγ and IL-2, producing high levels of the TH1 cytokines but minute amounts of TH2 cytokines suggesting a robust, TH1-biased T cell adaptive immune response.
The large-scale in-human Phase 2/3 trial has now enrolled over 25K participants. The companies reiterate that they remain on track to seek regulatory review as early as next month.
PFE up 1% and BNTX up 5% premarket, both on light volume.
Pfizer/BioNTech to supply 200M COVID-19 vaccine doses to European Union
Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have concluded exploratory talks with the European Commission for a proposed supply of 200M doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2.
Deliveries would be starting by the end of 2020, subject to clinical success and regulatory approval.
Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites and Pfizer’s production site in Belgium.
The companies are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if approved, plan to supply up to 100M doses worldwide by the end of 2020 and ~1.3B doses by the end of 2021.
See PFE and BNTX total return performance vs. peers over the past six months.
TherapeuticsMD nabs new U.S. patents covering contraceptive Annovera
TherapeuticsMD (NASDAQ:TXMD) announces that, on September 8, the USPTO issued a second patent (No. 10,765,628) covering Annovera (segesterone acetate and ethinyl estradiol vaginal system), its long-lasting reversible contraceptive for women.
The company says a third patent, No. 10,780,047, should be issued on September 22.
They will be in effect through 2039.
Shares up 1% after hours.